A Prospective Multicenter Study to Determine the Usefulness of Systematic 18-FDG-PET-TC for the Management of Invasive Fungal Infection (PETIFI Project)

Design: National multicenter prospective cohort study . Participating centers: 14 Spanish tertiary hospitals (see work plan)

For inclusion in the study, two types of IFIs will be considered:

• IFI in the form of fungemia: detection of fungal growth in blood cultures.
• Focal IFI with tissue invasion: patients with a diagnosis of proven or probable IFI according to the corresponding criteria depending on the type of patient (Hematology and other immunocompromised: European Organization for Research and Treatment of Cancer (EORTC)/Mycoses Study Group Education and Research Consortium (MS GERC) consensus definitions; solid organ transplantation: 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients; ICU/Chronic obstructive pulmonary disease: Bulpa criteria; COVID-19 (Coronavirus disease-2019): ECMM (European Confederation of Medical Mycology)/ISHAM.

Sample size:

Based on the literature, we assume that 18F-FDG PET-CT will detect lesions not previously visualized in approximately 50% of patients (7). We anticipate that the findings in 50% of these patients will cause the management of IFI to change, which corresponds to 25% of the total number of patients. To achieve a 6% accuracy in estimating a proportion using a bilateral 95% Normal asymptotic confidence interval, assuming that the proportion is 25%, it will be necessary to include 201 patients in the study. Assuming 10% of abandonments, or loss of information, it would be necessary to recruit 224 patients.